The calendar year 2022 has been particularly good for the development of laser and optical devices with a focus on acne, most recently with the Food and Drug Administration’s clearance of the Accurate Laser System in late November, for the treatment of mild to severe acne vulgaris.
This was preceded by the FDA clearance of AviClear, marketed by Cutera, in March, and the commercialization of TheraClearX, marketed by StrataSkin, in July.
“It’s an exciting time to be working with acne,” Fernanda H. Sakamoto, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. “We’re going to see a lot of people using new devices. I’m looking forward to seeing long-term results.”
AviClear and the Accure Laser System, marketed by Accure, are both powered by 1,726 nm lasers, but they work differently. AviClear, cleared to treat mild, moderate and severe acne, has a peak flux of 30 J/cm2 in single-pulse mode and a maximum flux of 20 J/cm2 in dual pulse mode. The treatment handpiece has a built-in scanner to deliver treatment spots in a pattern selected by the operator. “It is slightly lower than the Accure and has a maximum pulse energy of 5 joules and a pulse duration of up to 50 milliseconds,” said Sakamoto. When treating acne, laser and light treatments target the sebaceous gland.
In pivotal data submitted to the FDA, 104 acne patients enrolled at 7 sites in the United States received 304 treatments of AviClear at 2-5 week intervals. Each treatment took about 30 minutes. Treatment success was defined as having at least a 50% reduction in inflammatory acne 12 weeks after the last treatment visit, compared to baseline.
At the week 4 follow-up visit, there was a median and mean decrease of 42% and 37%, respectively, in the number of inflammatory lesions from baseline (P <.001). The researchers found that at the 4-week follow-up, 36% of patients had achieved treatment success, which increased to 78% at the 12-week follow-up visit. Treatment was considered safe and tolerable, according to the manufacturer.
The other newcomer with a wavelength of 1,726 nm is the Accurate Laser System, which features a smart laser handpiece for real-time thermal measurement and precise laser beam delivery. The device received the CE mark in 2020 for the treatment of moderate acne and Nov. 22, 2022, the manufacturer announced that it has been approved by the FDA for the treatment of mild to severe acne vulgaris.
Sakamoto and her colleagues at Wellman have worked with five dermatologists to conduct clinical trials of the device: Emil Tanghetti, MD, and Mitchell Goldman, MD, in California; Roy Geronemus, MD, in New York; Joel Cohen, MD, in Colorado; and Daniel Friedmann, MD, in Texas. As of Oct. 2, 2022, more than 50 patients with mild to severe acne were enrolled in four studies, and an additional 30 were enrolled in a pilot facial study, Sakamoto said. In the studies, patients are followed 4, 8, 12 and 24 weeks after treatment.
Among patients enrolled in the facial acne trial, researchers have seen a 100% response rate in patients with more than five acne breakouts at 4, 8, 12, and 24 weeks post-treatment after four monthly treatment cycles. The mean reduction at week 12 was 82% and the mean visual analogue scale immediately after treatment was 2.09 out of 10.
Each patient received more than 12,000 actuation forces from the device overall with no adverse events reported. After 12 months, they saw a 90% reduction in inflammatory lesions from baseline and a rapid response to treatment: a 73% reduction after the first two treatment cycles. Histological studies revealed selective destruction of sebaceous glands without damage to the epidermis, surrounding skin, or other skin structures.
Sakamoto emphasized that until now, there has been no direct clinical comparison between the AviClear and Accure devices. “Are all 1,726 nm lasers created equal?” This is a question we have to keep in mind,” she said at the meeting, which was sponsored by Harvard Medical School, Massachusetts General Hospital and the Wellman Center for Photomedicine. “They use the same wavelength, but they are different types of lasers.
For example, Accure Laser treats temperature, relies on air conditioning, and is aimed at dermatologists and plastic surgeons, while AviClear treats flow, relies on contact cooling, and includes spas and other non-medical providers as target users. “Mathematically, the difference between the two devices is that Accure can achieve deeper penetration in a single pulse, while AviClear is a little more superficial,” she said. “Whether that translates clinically is unknown at this point.”
Sakamoto also discussed TheraClearX, which is FDA-approved to treat mild, moderate, and severe acne, including: The device, a new version of the Palomar Acleara, uses vacuum technology with pressures up to 3 psi combined with broadband light with a wavelength spectrum of 500 nm–1,200 nm delivered through a liquid-cooled, hand-held delivery system. The exemplary device was the Aesthera Isolaz System. The vacuum pulls out the build-up of fat. “At the same time, it takes the blood out of the competitive chromosome,” she said. “In doing so, it potentially damages sebaceous glands and reduces inflammatory damage.”
Sakamoto disclosed that she is the founder and scientific advisor of Lightwater Bioscience. She is also a scientific advisor for Precise Acne and has received a portion of patent royalties from Massachusetts General Hospital.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.